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I have never launched a me too product, each one has been a new mechanism of action, at least for that disease state. Each one has provided a meaningful benefit to an unmet medical need, although a couple only to a niche group within a population. I work in the US and launch means approval.
Yes, back in my early days of my career, a BLA submission was done with hard copy and it took two semi trucks to transport the package to FDA. It is all electronic now as is the CRF and really the whole Western world. When FDA is motivated by saving lives, they too race to review the package and approve with urgency. Me too products though have to wait until the exact standard PDUFA date and may even be extended at that time.
Two were absolute break-through technologies. One was published in one of the top 3 journals with a corresponding editorial in one of the other top 3 journals calling it the most important medical advance since Dr. Saulk invented vaccines.
My DD also suggests with a high degree of certainty success…so what is the issue with presenting data a timely manner?
My team ran 24 Advisory Board in the past year. Average time inception to completion was about 8 weeks with the shortest being just over 4 weeks for an urgent issue. Convening the SAB virtually is not a difficult task, even during COVID. Data analysis can be as short as 1 day, but 3 weeks is still reasonable, even during COVID. LL could write the intro to a publication in her sleep and LL and KA seem quite motivated to collaborate on the rest of the paper including the Discussion section with urgency, even during COVID. Congress have continued without cancellation, even during COVID. And journals conitnue to review and publish without delay, even during COVID.
So what the hell is going on, even during COVID?
Management did say they would announce TLD in close proximity to a congress and before publication. You are right, they did not say SNO.
What the hell, ASCO is only 6 months away. Why is anyone upset that they may not be presenting data at SNO? It is only 13.5 months after data lock.
One of my former companies had a personal best BLA filing goal every time they closed a study. Their best was 8.5 weeks. I doubt they will ever beat that record, but it is a goal. Obviously, TLD release came before the filing and data was presented at congress before both. You may say that is not possible, but you are WRONG. It was a very unique situation. Uniqueness can be an advantage.
- Management never said they would do an RFP for manufacturing partners and identify the speediest, best managed, most cost effective approach for its investors.
- Management never said they would hire a CFO
- Management never said they would file quarterly reports on time.
- Management never said they would hold quarterly or annual investor calls.
- Management never said they would stick to the registered stock shelf.
- Management never said they would share a financial viability plan
- Management never said they would require legitimate milestones to reward leadership with enormous stock options or grants for a job well done
- Management never said they would wait until they were close to commercialization to build a huge booth and blow hundreds of thousands of dollars on exhibiting at conference with that huge footprint.
- Management never said they would continue that practice as they approach an anticipated data release
- Management never said what would ultimately trigger the end of the phase three trial.
- Management never said they would lock the database within 22 months after November 2018 announcement that they would begin the process of locking the database.
- Management never said they would hire experienced industry professional(s) to manage the regulatory process or build a commercialization strategy.
- Management never said they would hire consultants to support regulatory submission or commercialization
- Management never said they would present their data at scientific medical conference.
- Management never said they would file a BLA within one, two or even three years of locking the database.
- Management never said they would share TLD with their investors in a timely manner
- Management never said they would share negative feedback from regulators
- Management never said they will follow pharmaceutical industry best practices or any other industry best practices for that matter.
You are not a REAL long unless you have absolute blind faith that management has your best interest as an investor or as a patient with GBM in mind. REAL investors march lock step behind management where ever they choose to secretly lead you.
Thank you for clarifying that my 8+ year long position isn’t REAL, but please don’t tell my wife or she may divorce me for embezzlement of family resources.
Thank you Doc. I continue to hold you in the highest regards for whatever that is worth to you. Hopefully, I will be able to share a very expense bottle of wine with you some day while we celebrate our perseverance.
I respect all longs who have persevered through this experience whether or not they agree with me some or all of the time, but not necessarily if they have offended me without justification or an apology.
LL presented the statistical model, outline of the SAP and made forward looking statements about DCVax that implied efficacy. That is a claim.
They owe us all timely results and maximizing the value of the asset. When opinions translate into action or inaction on a asset, they cross-over into responsibility. It is not just my opinion that maximizing the value of a drug product includes presentation of results at a major scientific congress, it is industry standard.
Biosect, BTW your logic is falling apart. If they are following ‘their plan’ then they are submitting to a journal with or without full FDA buy-in. Or are you suggesting that they haven’t even submitted yet or even by the late-breaker SNO deadline?
With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.
The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.
She can just give herself and her cabal stock options for achieving some other Bull$hit milestone to counter the dilution. What power do we have to stop that? WTF did the JTM publication accomplish other than subduing retail for a few more years. I think we hit $0.14 after JTM if I recall correctly. We shareholders were fleeced out of those options PERIOD!
The approved shelf doesn’t even phase them.
Biosect, If they chose Neurooncology there is absolutely no doubt that they can present at SNO. The choice was theirs to make. They are responsible to shareholders and LL/UCLA for these decisions.
So what is your opinion of the LL presentation to Mt. Sinai then? She is employed by NWBO and represents DCVax in the eyes of FDA and OIG. It is called Safe Harbor when it is a scientific session. FDA can and will revise the statistical analysis to their liking at the time of review whether or not LP and LL agree. The outline is supposedly agreed upon.
Yes, that is what Biogen originally thought about Spinraza but quickly realized they needed a massive effort to sell that drug. Without Spinraza tens of thousands of children with SMA would be dead or more permanently disabled on the path to death. Without the herculean effort from big biotech, Spinraza would have sat on the shelf of distributors until it expired and no new orders would be placed. That billion dollar investment would have been lost and IONS would be teetering on bankruptcy.
Spinraza to DCVax is a Honey Crisp to Golden Delicious comparison. There are only 600 pediatric muscular dystrophy specialists in the US. If it can’t happen by osmosis there, it can’t happen anywhere.
Great drugs don’t sell themselves. Physicians don’t have time or resources to figure it out themselves. Insurance companies don’t want to pay for squat either. Good luck getting your technology reimbursed without the experience, expertise and leverage.
I was once involved in a final meeting with the CEO and CMO of United Healthcare where we told them if they do not cover our drug any longer we will be funding and even advertising to encourage every single lawsuit against them. The drug saved lives, thousands of them each year which could be proven with data. I never saw a billionaire get so angry, at least before QANON existed. They changed coverage policy by the time I got back home.
Right on the money. I have been working with providers in multiple disease states for over 20 years. Education for most all of them stops when the graduate residency or fellowship. Without industry sales people, dinner programs, medical staff, etc. they would not be able to stay even remotely updated. Most will admit that, especially if their institution does not allow sales people access. Those physicians often flat out complain about it.
I spent my last personal specialist appointment educating one such young specialist about the last 2 drugs approved in his specialty. He literally told me “I don’t have time to educate myself and I have young kids so I can’t go to conferences. I hate that my institution blocks pharma out because I rely on people like you to keep me informed.” They are not my companies drugs.
The mothership of that institution won’t let our sales force in, bad mouths our marketing efforts, but has no problem strong arming me for a $50k grant to support their research foundation which by the way is trying to develop competition for my current company as well as our competitors. Perhaps, we can buy back our investment for a few hundred million when the time comes. How about them ethics?
Happens all the time at “restricted institutions.”
You are in neurology so perhaps you know this…if you want to be treated with the latest and greatest neurological therapy from 20 years ago, go to Mayo clinic for treatment. They hate industry, but never mind that they are one of the biggest diagnostics companies in the industry and never mind that they exploit loop holes in the diagnostic approval options to get those diagnostics to market or that they reap hundreds of millions in profit doing so. That is ok because they are not industry profiteers.
PGSD, SNO and ASCO are big, ESMO is medium and these are congresses. Phacylitate is a tiny conference for highly specialized scientists and industry.
Go to SNO or go back to court. That is the option she has now. While she may win another round of court cases, where will she get the capital to fight and stall retail investors some more. Who will invest new money when the ambulance chasers come back? Which one of us will sign as as lead plaintiff? Who will LL side with and what does she have to say when she receives a subpoena?
IDEC sold Rituxin and follow on products to Genetech for $200M and substantial royalties. Rituxin was the largest grossing drug in history before Humira displaced that title. Biogen Idec kicked themselves for decades later and small biotechs literally quoted that deal as the example why they wanted to go it alone for years and years…most all are no longer around either from self-combustion or later acquisition while Biogen was one of the big 3 biotechs for decades. They would not have made it without Rituxin deal money and Genetech’s marketing prowess. I would call that going big considering their market cap is in the neighborhood of $80B today and combined the BIIB combo was worth less than $1B at the time of the Rituxin deal. Without the deal, they likely would have been going home after pulling Tysabri from market.
Is there anyone bigger than Merk, BMS, JNJ, Roche or Novartis? Well, yes Tesla, Microsoft, Amazon and Alphbet but not any start up biotechs. Amgen is close I guess, maybe Gilead. Going BIG would have been striking a deal for DCVax-L and developing DCVax-D.
Do you realize that we could be anticipating the first Direct approval right now instead of waiting on data for L if they had the cash to actually run an efficient Biotech business? It has been on the shelf for more than 6 years now…I am getiing to the point where I want LP to go the frack home and allow us to go big, but it may be too late for that already. Time is money and mRNA is around the courner. You wanna bet on who has more oncology approvals in 4 years, Moderna or NWBO?
My money should have been on Moderna all along. I just didn’t have the free cash available when they were $50 and offered me a job. Mainly because I have been bound and gagged by LP. I also should have taken that job, but hindsight is 20-20 and I like my current digs quite a lot as well. I just would have liked the jackpot more.
100% agree on my end too. We shouldn’t have gone this far without a partner, but that is hindsight mostly. There was opportunity before the phase IV-Cognate debacle, but according to LP the only thing BP brings to the table is money. That statement should have been my clue that we were going to go down a long and winding road of uncertainty with amatuers. BP brings so much more than money to the table, but money itself is one of the most important factors for a small start-up biotech. Another thing they bring is FDA relationships, but that is a small piece of what they bring to the table.
I love Mav’s BioNtech example. Did Pfizer just bring money to that table? Seems to me that we would be seeing at least a few hundred thousand more US deaths from COVID and an economy that may never recover if BioNtech had the same attitude LP has.
Survivor, I put it out there publicly so have at it. I assume every email I write will be forwarded and any message I put on this board may be read by management.
They fracking called me out at the last ASM. If I am not one of posters who was setting ASCO expectations, then who the hell were they referring to? That is called precedent and it was established before the last ASM, not with me but with this board.
Biosect, you know this too…data and analysis ultimately approved by regulators frequently differs from data presented and published…sometimes substantially. That goes for safety as well as efficacy.
The two are independent.
Also regulators can be incredibly quick with feedback and approval when the drug is for high unmet medical need in a fatal condition...i.e., GBM.
I understand your point of view and your wanting to defend your investment. The company reads and responds to this board. It is important that they know we are sick of the silence. If they miss SNO and don’t provide guidance at the very least, Things will get ugly and LP is to blame.
And BTW Congress presentation is PEER REVIEW, not only by my standards but by FDA as well. You can market data presented at Congress without it being published.
Biosect, I am usually right there with you defending them and will revert back to doing so if they get the data out soon. I am not sure if I am part of where these comments are directed or not. I don’t really care and don’t hold grudges. You know that Regulatory process and manufacturing are not linked to publication process after the SAP has been filed.
IMO they have handled RA well, Advent manufacturing build out well (not so much regarding Cognate and the 875 million CRL paid for Cognate a few years ago for basically our investment proves that to me), and financial survival well too but after the Cognate investment BS. TLD release…not so much. If they miss SNO, then IMO not at all. If they had extensive pharmaceutical experience on their small team, then I could be talked into giving them more time, but they don’t.
COVID Schmovid at this point as well. After meeting with one KOL last week, he told me that he would be spending the next day and weekend reviewing a dozen submissions for publication, like he usually dose twice a month. They are dealing with white collar, work from home stuff now with regards to TLD. COVID is not a reasonable excuse any more. It is not impacting Congress presentation or publications. Things are back to normal now, and have been with regards to publication for a long time now. If they try to use it again, they will lose support.
While I think a steady drum beat of positive news will help lift this stock to where it should be at this point in the game, I don’t buy the argument at all that shorts can pick apart a Late-breaker plenary presentation more than they can a publication. If new money plans to join the party, that will begin after a successful presentation. It does not have to be timed with manufacturing news or regulatory news. Major congress presentation of pivotal trial data gets the attention and support of the target market and can stand alone as fuel for attracting investment. The thing about publicity is that you want as much of it as you can get. Limiting yourself to publication, limits the number of substantive PRs and the attention from both the medical community and the investment community.
Cliches are cliches because they are usually true…and ‘there is no such thing as bad publicity’ (especially if that is based on positive news).
Maverick, SNO is their last chance to show me they know what the hell they are doing. I have been supportive, I have been patient. I have also seen results turned into TLD release within weeks of data lock. I have seen this with great big companies and relatively small companies. I have seen this with a product that was stopped early and quite complicated in both the data and the delivery. In fact, it will probably be the most difficult product ever delivered to market and it was a blockbuster. I had heavy hand in making that happen. That data was released immediately, presented quickly, approved in a flash, and published oh about a year and a half later. The drug I am currently launching just got published about 6 months after approval and more than a year after presentation because that is how it is done. If it is not broken, and this process is the opposite of broken, you don’t try to fix it.
If I am to believe that the SAP was shopped around and received positive feedback from all including the only regulator that really matters, then any discussion of data complications leading to delay after data lock is absolutely bogus! You can’t have it both ways, either there was buy-in and things were relatively straightforward or there was not and things are messy. If that is the case, it is material information and should be disclosed to investors in a timely manner. A year and a quarter is way past timely.
I understand that the company was cash and resource strapped. Besides the fact that LPs decisions regarding Cognate are a huge piece of that equation, we seem to be able to afford two uplisting consultants way ahead of actually being close to uplisting, but we can’t afford a good medical writer, a publication planner or regulatory consultants?
You know what, we have a sayin in industry… time is money. She is out of time and out of money. Submission deadlines for SNO were well within reason. What is not within reason is not presenting the data at SNO.
Present the damn data already. I am sick and tired of excuses, ill-informed explanations, and all that other Jazz. Show some competence and present the damn data at a major conference like SNO. You want to show that you have no idea what you are doing, then present at some other little conference after SNO but before ASCO. That will make everyone from Wall Street to Main Street, Mayo to MD Anderson and all other Oncology Meccas believe in your data…NOT. Your target audience is SNO first, ASCO second, and ESMO third. Target audience…if they don’t understand that concept, they are clueless amateurs. That is where Neurooncology goes to learn and pound chests, AND medicine is back to live conferences. I just came from one and it had solid attendance with virtual participation to boot.
That is kind of like publishing in JTM rather than NEJM or Neurooncology. The world took notice of that one, remember? What a rocket ship that publication produced. That countdown only took about two and a half years for a successful test launch. Now add another year and a quarter and people here are trying to temper expectations. Has anyone considered that LLs reputation will suffer a little bit and that faith in the data could suffer quite a lot if they miss this opportunity?
Drugs that get delays usually have expectations drastically reduced because the delay creates doubt and competitive opportunity. Anything after SNO will be hard to explain to the medical community and is a delay. Using Wall Street as an excuse will likely have the opposite of the intended affect with physicians, especially if this drug is priced anywhere near where it is worth.
If they are not presenting at SNO, they better have a damn good press release or we will have Big Trouble in Little China. I don’t know how much longer I can hold my allies together on this one. They will start to bail soon which is probably the intended consequence to deciding to skip SNO. No SNO and I am fully on board with the idea that the subsequent stock drop is engineered for insider friendlies to buy low when the next raise happens.
Agree. But by submitting a placeholder when the company clearly could not make it happen, LL stuck a stake in the ground. My opinion, she wants to present and she wants to present at SNO. I should have seen this earlier with ASCO. She may be able to submit a placeholder without LP buying in, but she can’t present anything without NWBO data and approval. The combo study is different, it is an Investigator Initiated Trial. She doesn’t own what is done with the technology, but she does own that data.
No SNO is all on LP and it is a horrible decision, but what do I know. I’ve only launched 10 more drugs than her.
Doc, I really don’t like contradicting you, but have you ever worked with a medical conference? Attention is just about the only thing they do care about and they want all of it and any of it because that translates into registrations and sponsorships. Good, bad, ugly, they generally welcome everything as long as you follow their rules and give them money. The more money, the more voice and influence.
As I said, medicine discounts industry. Industry makes up about 30-40% of registrants and almost all other funding which is the majority share. Conferences don’t happen without us. They usually enjoy and sometimes stoke the competition and chaos.
If we are not at SNO, it is only because LP says so which is why I have a beef about the likelihood that SNO will come and go without TLD. LL showed us her preference last year.
‘Zero indication’ is not true BTW. LG said on the Big Biz Show that conference presentation would occur in close proximity to TLD release. They never said SNO, so we are left to speculate which, but I don’t recall this public statement ever being corrected. The later omission on the same show did not come across to me as a correction to a different plan, but rather a summary statement that neglected details. Reconfirming a plan to publish at ASM also does not correct this statement, rather in my mind it confirms the statement.
If not SNO, how about they share their timing for their plan for release like every other Biotech. By now, they know whether the first journal they submitted to plans to publish and if they moved on to number 2 it should be to a journal that provides a slam dunk at the highest Impact Score possible, like for example Neurooncology.
Troc, Because to publish without presenting first is basically pharmaceutical malpractice. That is why there is anticipation for SNO.
I am happy to reverse this opinion if anyone can show me a couple examples of blockbusters that have followed that path because there are thousands of examples of the proven pathway. I’ll settle for the needle in the haystack as long as there are a few needles, one or two needles are happenstance.
If SNO comes and goes with no news, I think we are in for quite a rocky road and destruction of shareholder confidence and value…not the actions of an ‘ownership’ team that pays attention to minority shareholders. The ambulance chasers will likely kick in again and this time they will have plenty of investors ready to sign on to a class action suit. That alone will fuel further destruction and distrust which will clip the wings when they do feel it is finally appropriate to update their shareholders after more than a year of silence.
My fear is that may just be the insider plan after all… probably impossible to prove given the attorney’s at the helm, but plausible given the attorney’s at the helm. I don’t put high probability on this idea, but the fact that I place any reasonable probability to this is probably why we are not seeing a rally going in to SNO. That and the possible ‘friendly’ dumping of shares.
LL has done heavy lifting to maintain interest in DCVax and that should be rewarded with a Plenary presentation of Late-breaking results. If it is not, I will become a believer that the subsequent stock drop is actually engineered by management and part of the plan.
Mav, I have stopped believing that despite the silence everything behind the scenes is moving in the right direction and at an appropriate pace. I am no longer convinced. It may be, but past history tells me that it may not.
I totally agree with you that the lack of industry experience at NWBO is either a sign of incompetence or evidence that a deal is already in the works. I am just not convinced about either option. LL and KA keep me motivated and have continued strong support for DCVax. I do not extend this to support for management. The opposite actually, I believe that I have sensed frustration from LL. Initially, I chalked that up to the fact that practicing physicians really have no idea how much effort and resource goes into drug development, approval, and market, and almost universally discount the value that industry brings. I also find medicines’ ethics with regards to business practices to quite often be incredibly simplistic and often very, very, very, very, very hypocritical. (I think that gets my point across, but if the physicians on this board are offended I will be happy to rattle of a litany of examples). I am a firm believer in the value of medicine as is most all of industry, but just wish medicine recognized the reverse and realized that we are allies not adversaries. So I generally don’t pay any attention to this type of frustration and/or judgement.
LL, however, strikes me as very knowledgeable about business, RA and industry as well as ethical to the highest degree. I think that if SNO comes and goes without TLD, we may see her get quite vocal with criticism.
TLD isn’t the time to sell regardless. It is after FDA approval, but I agree with your premise. I meant that I may not stick around to see them flop through a launch of this drug on their own. There is a reason most biotech sell out these days, the barriers to entry and successful execution are great. If they can’t pull off an efficient presentation, publication and RA strategy, then they certainly can’t launch well.
If they can pull the first part off, there is hope for them going alone or taking time to negotiate a great deal with a partner. That could obviously take this rocket beyond pre-orbital space and out into the galaxy. So much depends on the next few months and what they have been cooking over the past 3 years.
Are they a ham and egger or are they French cuisine? I honestly don’t know anymore, it could go either way.
A tradition enforced by FDA. FDA gives you a generic name and approves your proposed Brand name. The name cannot look or sound like something that has come before. FDA does not like when companies use and trademark a name before their approval of a name as this is called pre-market promotion.
Antigren was a well accepted trademarked name for the anti-integren drug that ultimately became known Tysabri (natalizumab) for example. FDA would not let Biogen keep the name that Elan gave it, everyone already knew and easily identified as the product and MOA.
It will not be called DCVax when it comes to market. They shouldn’t have chosen to name the product so generically as it begs other copycats to hitch their wagon to it. It would not have been hard for them to do a little research and see the writing on the wall. I don’t think it was a bad idea to brand the product pre-approval, but do think they should have put some more thought into ithe name they used. Rookie mistake.
Bob, If they still plan to go it alone, that is not a good sign for a speedy approval. I am not sure that I can stick around to see if they can build a successful commercial operation in that case. Fortunately, if they aren’t working on a partnership or BO now, they may not have much of a choice after TLD. I think there is a high likelihood a hostile takeover bid would be coming from some BP. The upside will be too tempting to pass on and I don’t longs will have the stomach to pass up an offer, I know that I won’t.
Gus, I don’t think we are waiting on FDA to approve the new endpoints. That process started three years ago and even if NWBO has mastered the art of dragging ones feet, FDA actually moves faster than that. I honestly believe that if the NDA process has not begun, there is only one person to blame and her last name is not Liau.
However, I believe that progress has been made and we are about to see a can of whoop-@ss opened up on shorts. I have just been wrong about timing so many times before that my faith is skin deep. I think competent or incompetent management aside, DCVax is worthy of Billions in market cap. How many billions is the question?
If LP has mastermind a series of positive news including regulatory news beyond UK manufacturing certification, then this could be a very large number of billions. If not, I still think we see at least $4 which is $5.5B market cap. Still a big win for most longs, but one that doesn’t make up for the opportunities I missed out on. I will be a disappointed investor, but I will get over it.
WE, I disagree. Presentation of the data is important to the product value. If you want to maximize the BO offer, you want your product seen in the most favorable light. While I appreciate the physicians on this board, some believe that publishing first is the best way to influence the market. Physicians frequently discount the value add and expertise of industry. Physicians may not appreciate or like the influence of industry, but medicine does not adopt new technologies without the herculean efforts that happen behind the scenes. It is naive to think that physicians are reading journals in their spare time. They aren’t. They are guided to read certain articles, either through personal passion sometimes, or through peers and/or industry guidance most of the time which begins with the hype generated at congress.
Jester, hmmm…interesting theory, unfortunately that is not how it works. UCLA does not have that right.
Let’s look at Spark as an example. Spark was essentially spun out of U Penn and they continued to have a prominent role in the work and output from Spark. But the press releases, presentations and eventual publication were determined by Spark. And BTW, this ground breaking gene insertion technology followed the tried and true methods… presenting then publishing. And U Penn did not call the shots or host press conferences…once their baby, but not their baby any more.
https://sparktx.com/press_releases/spark-therapeutics-announces-presentation-of-additional-phase-3-data-on-spk-rpe65-at-the-american-academy-of-ophthalmology-2015-annual-meeting/
Bob, Unfortunately I don’t think UCLA had many alternatives at the time, but I agree that there is likely some regret. I understand the likely reasons why we are where we are, think up until now management has done as good a job as possible given the headwinds they have faced, and still hold out hope that they will get this right.
Having said that, I am concerned that they believe TLD publication is the finish line to commercial success…not even close.
We do not know yet what steps have been taken regarding RA submission and approval. If we are subject to a standard review and have not yet submitted the application….incompetence. If we publish before presenting…incompetence. If we think we can hire and train a successful commercial operation ourselves in time to launch a blockbuster in 1H2022…incompetence. If this drug is not launched in some major market before Q4 2022…incompetence. Time is money and when it comes to GBM, there is no making up for lost lives and lost revenue.
There is still a chance that all or most of these things are addressed behind the scenes. Unfortunately, we retail investors are left to guess and speculate. This may be due to a grand plan coming to fruition, or it may be incompetence. We will soon find out which is true and what that means for patients. As an investor, I believe this asset has great value even if we are saddled with incompetence, it just wont be maximized for us in that case.
Foxhound, if you read more clearly my comment it is not a prediction for release at SNO. I have little faith that there will be a presentation at SNO but hold out hope.
SNO means nothing to the short or long term success of DC-Vac. I continue predict that you will eventually get TLD and announcement that a publication is in the works.
Ski-T, it is my recollection that on the Big Biz Show, LG clearly stated TLD will be released in close proximity to a congress presentation followed by publication. He later left the congress step out, but I agree that they have never said that they would not present the data first while at the same time insisting that they are working on a publication.
While I am not confident that we will see a presentation at SNO, I am absolutely confident that it would be a very big missed opportunity if we do not and that LL would want to present the data before publishing. The 2020 placeholder abstract that you mention is evidence to this belief about LL in addition to my many years working closely with physicians in similar situations. They always want to present the data to their peers. It is a big part of the process.
I will be patient and I will not sell before TLD, but missing out on SNO will be a signal to me that management does not know what they are doing when it comes to successfully launching a product and that LL has little influence within NWBO. I will be worried for the first time in years. Not about the data and not about the KOL support, but I will be worried that management is incompetent. Not presenting the data will have a negative impact on belief in the product, even if published in a top tier journal. Consensus is built at congress. I witnessed this again firsthand last week.
Missing out on the big congress reveal is strong measure of pharmaceutical incompetence.
I leave this morning for vacation, and will leave you this morning with one of the greatest concerts ever recorded in history. The first song is a fitting song to run through a brain as I think about SNO and what will likely be accomplished there.
Drs. Linda Liau and Keymours Ashkan have already said that DCVax is their greatest accomplishment. This coming from two incredibly accomplished human beings. I know that I would want the stage to release word of a cure for cancer. Do they, or can they wait for a publication followed by a few emails of congratulations, maybe an invite to Grand Rounds here and there? Is that how you do it or do you shout from the mountaintops and parade through the streets for a week?
Mt. Sinai is one of those mountaintops, both biblically and clinically.
PGSD, It is not a coincidence at all. UCLA David Geffin School of Medicine is world-renowned in all things neurology from craddle to GBM. The last part is due in large part to LL. Her colleagues there and on the JTM paper are the top researchers in the world. So of course they would all show up to the biggest Neurooncology congress, as will many other healing hands and great minds.
Seems like the perfect place to release the results of the century from the longest registrional clinical trial in history, demonstrating a rather large proportion of treated patients are cured by DCVAX of the most deadly form of cancer known to man. Someone who won their lifetime achievement award could display all in front of her esteemed colleagues with support from across the pond who can attest that his patients are all living longer too, and that if the Queen had brain cancer of any kind, he’d be giving her DCVax.
SNO would be ideal followed shortly by a big pub just as LG shared with us over a beer at The Big Show. That would be close to perfect if one could pull it off. Can LL?
That is who submits, LL.
Impact Factor risen to 12 that is pretty high.
https://academic.oup.com/neuro-oncology/pages/About
How possibly could you present at the meeting of the Society of NeuroOncology and publish without breaking embargo policy?
I am not worried that they can publish. The question is whether or not NEJM or Lancet will accept them. The alternative is a pretty good option.
There is no delay whatsoever in publication. The timeline on publication is tracking in line with standards. One can argue a delay in TLD reporting, but they chose to communicate with medicine and wallstreet simultaneously rather than the usual two step.
The two step generally angers providers BTW. They believe patients and physicians befor investors, but the law says otherwise.
Define Foreshadowing…
If a picture is worth a thousand words, a video presentation is worth a gazillion.
No concerns, it is coming whether NEJM or Neurooncology…it is coming.
SNO should be next, then MHRA, then….then…then…
SNO and Neurooncology are connected, so coordinating is easy, breezy. In April, the database was built and in a fashion presentable for publication. This tells me that the paper on DCVax was close to buttoned up. We are almost six months from that point. Tick, tock, tick, tock
Reactive…vindicated…reassured